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Recruiting NCT05779462

ENDOMETRIOSIS - MRI

Observational Endometriosis Mobility Limitation Magnetic Resonance Imaging Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dynamic MRI Sequence.
Who it may be relevant to
Registry conditions: Endometriosis, Mobility Limitation, Magnetic Resonance Imaging, Diagnosis. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis

Overview

Endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age. There is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult. It therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented. The clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively. The persistence of hypo-mobility could also help to understand treatment failures.

Interventions

  • Other Dynamic MRI Sequence
    Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care

Primary outcome measures

  • the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI [Time frame: Baseline]
Secondary outcome measures (4)
  • the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI. [Time frame: Baseline]
  • the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI. [Time frame: Baseline]
  • the measurement of variation in mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort between the initial dynamic MRI of patients with [Time frame: Baseline]
  • the statistical association between the symptoms of patients with endometriosis and the mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort during dynamic MRI. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Patient referred for suspected pelvic endometriosis requiring pelvic MRI
  • Female, nulliparous,
  • patient with signed written consent, patient with health insurance,
  • patient willing to comply with all study procedures and duration

Exclusion criteria

  • BMI > 35,
  • history of hereditary collagen and elastic tissue disease,
  • history of pelviperitonitis,
  • history of major pelvic surgery,
  • inability to receive informed information,
  • inability to participate in the entire study,
  • lack of social security coverage,
  • refusal to sign consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service de chirurgie gynécologique Hôpital Jeanne de Flandre - CHU de LILLE — Lille

Identifiers

NCT: NCT05779462 · 2022_0032 · 2022-A02135-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗